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The MyAllergyTest System is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum samples. The MyAllergyTest System may only be run on the Luminex 100TM Integrated System Version 2.0. The MyAllergyTest™ System is used as an aid in the clinical diagnosis of IgE mediated allergenic disorders. Measurement of allergen specific IgE antibodies may aid diagnosis of asthma, allergies, and other pulmonary disorders.

MyAllergyTest™ System is a test for the measurement of allergen specific IgE in human serum. The MyAllergyTest™ System consist of two components: 1. MyAllergyTest™ System Reagents. 2. MyAllergyTest™ System support software for the Luminex 100m I S Version 2.0 A serum sample is mixed with allergen specific coupled microspheres. If present, specific IgE in the sample will bind with the microspheres and form an allergen/sIgE complex is then sequentially incubated with biotical ati-human IgE antibody and fluorescent-labeled-streptavidin. sequentially is present in the sample, the final sandwich complex of allergen/slgE/biotin-anti-It specific is the summers, Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of allergen specific IgE in the sample. The MyAllergyTest System may only be run on the Luminex 100m Intergented System Version 2.0. The MyAllergyTest™ System specific software for the Luminer 100m Integrated System Version 2.0 will simultaneously measure and identify allergen specific IgE concentrations.

The provided text describes the MyAllergyTest™ System, an in vitro diagnostic test for measuring allergen-specific IgE antibodies. The document presents a summary of safety and effectiveness, including performance data from studies conducted.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate set of predefined thresholds. Instead, it presents "Brief Description of Performance Data" with study results. We will assume these reported results represent the device's performance against implicitly accepted standards for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information regarding:

• The specific sample size used for the test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information regarding:

• The number of experts used to establish the ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not provide information regarding the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The study focuses on the device's performance characteristics (sensitivity, specificity, etc.) rather than on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The MyAllergyTest™ System is an "in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum." It is described as having "MyAllergyTest™ System support software for the Luminex 100m I S Version 2.0" that will "simultaneously measure and identify allergen specific IgE concentrations." This indicates that the device operates as a standalone system (algorithm/instrument only) to provide quantitative measurements, without directly involving human interpretation of images or complex data outputs that would require a human-in-the-loop performance study in the context of AI. The performance metrics (sensitivity, specificity, accuracy, precision) are characteristic of a standalone analytical device.

7. The Type of Ground Truth Used

The document explicitly states: "RAST inhibition verified the immunological specificity of the IgE binding for each allergen." This indicates that RAST inhibition was used as a method to verify the immunological specificity, which can be considered a form of ground truth or verification for the specific IgE binding. However, for the overall sensitivity, specificity, and accuracy, the specific "ground truth" (e.g., a reference standard test, clinical diagnosis, etc.) is not detailed beyond this verification step. Given it's an IgE test, a common ground truth would be a combination of clinical symptoms and established reference methods or assays. The document states it was compared to "Pharmacia CAP System™ Specific IgE FEIA" for substantial equivalence, implying the CAP system might have served as a reference or predicate to establish the "ground truth" for comparison for the performance metrics.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. It is an IVD device, not explicitly an AI/ML device where 'training set' is a standard term, though the underlying software would have been developed and validated.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information regarding how the ground truth for the training set was established, nor does it explicitly mention a "training set" in the context of machine learning model development.

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